The National Institute of Arthritis and Musculoskeletal
and Skin Diseases (NIAMS), National Institutes of Health, invites new and
renewal applications for Multidisciplinary Clinical Research Centers (MCRCs)
in arthritis, musculoskeletal disorders, and/or skin diseases. Each
MCRC will be organized around a methodology core. In addition to this core,
each center must include a minimum of two highly meritorious clinical
projects focused on diseases or conditions within the NIAMS mission (http://www.niams.nih.gov/Funding/Funding_Opportunities/Supported_Scientific_Areas/default.asp).
The methodology core will be the foundation of the MCRC, providing key
support for the development and implementation of clinical projects.
Each clinical project must address a critical issue that directly involves
prevention, assessment and/or outcomes for patients with chronic diseases or
conditions within the mission of the NIAMS. The MCRCs will build on a
meritorious research base and are expected to leverage existing institutional
infrastructure resources. Clinical trials will not be supported by this
funding mechanism.

Key Dates

Posted Date

January 10, 2012

Letter of Intent Due Date

April 18, 2012

Application Due Date(s)

May 18, 2012

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

Sept/Oct 2012

Advisory Council Review

January, 2013

Earliest Start Date(s)

April 1, 2013

Expiration Date

May 19, 2012

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in
the PHS398
Application Guide except where instructed to do otherwise (in this FOA or
in a Notice from the NIH Guide
for Grants and Contracts). Conformance to all requirements (both in
the Application Guide and the FOA) is required and strictly enforced. While
some links are provided, applicants must read and follow all application
instructions in the Application Guide as well as any program-specific
instructions noted in Section IV. When
the program-specific instructions deviate from those in the Application Guide,
follow the program-specific instructions. Applications that do not
comply with these instructions may be delayed or not accepted for review.

The
purpose of the MCRC program is to support a full range of outstanding
multidisciplinary clinical research in the areas of arthritis and
musculoskeletal and skin diseases and disorders. The goals of this program are
to support research on the prevention, assessment or improvement of outcomes
for patients with arthritis, rheumatic diseases, skin diseases or diseases or
disorders of the musculoskeletal system. For a comprehensive listing of
conditions that fall within the NIAMS mission, please see http://www.niams.nih.gov/Funding/Funding_Opportunities/Supported_Scientific_Areas/default.asp
For guidance on the relevance of a proposed study to the NIAMS mission, contact
the Program Directors listed below under “Scientific/Research Contacts.”

Each MCRC should be organized around a methodology core and
must include a minimum of two highly meritorious clinical projects. The
projects and overall Center can be focused on one or more disease/condition.
The methodology core must demonstrate that it can provide support for
multidisciplinary approaches for clinical projects within and outside the MCRC.
It is anticipated that some MCRCs may bring a multidisciplinary clinical
approach to closely related diseases or disorders for which there is a paucity
of clinical research nationally. Other MCRCs may focus on advancing clinical
research on diverse diseases within the mission of NIAMS. The scientific focus
of the MCRC may also be developed around already collected or ongoing
significant cohorts or other patient resources.

The methodology core is the foundation of the MCRC,
providing key support for the development and implementation of clinical
projects. The methodology core is expected to provide expertise and support to
ongoing projects within the research base of the MCRC and to other emerging
research opportunities funded elsewhere that are relevant to the NIAMS mission.
The methodology core is not expected to conduct laboratory assays, although
such may be included in an additional, separate core. The director of the MCRC,
aided by an executive committee and the methodology core, provides leadership
to assure a rigorous research approach and to focus all clinical projects on
critical issues relevant to disease prevention or to assessment and/or to
improve patient outcomes. The proposed director should document this leadership
with examples of the ability to network with colleagues from clinical and other
areas of biomedical research.

The MCRCs are expected to leverage existing institutional
infrastructure resources. A meritorious research base in patient-oriented
research, biobehavioral and social sciences, epidemiology and/or health
services is a prerequisite for proposing an MCRC. Each MCRC application should
define its research base, goals for promoting clinical research utilizing that
research base, and how multidisciplinary research will be promoted. Potential
interactions and/or collaborations with a Clinical and Translational Science
Award (CTSA), if present, must be documented.

Each clinical research project must address a critical issue
that directly involves prevention, assessment and/or outcomes for patients with
diseases/conditions within the mission of the NIAMS. Clinical approaches that
could be utilized by the centers may include, but are not limited to:

The NIH defines human clinical research as: (1)
Patient-oriented research. Research conducted with human subjects (or on
material of human origin such as tissues, specimens and cognitive phenomena)
for which an investigator (or colleague) directly interacts with human
subjects. Excluded from this definition are in vitro studies that utilize human
tissues that cannot be linked to a living individual. Patient-oriented research
includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c)
clinical trials, or (d) development of new technologies. (2) Epidemiologic and
behavioral studies. (3) Outcomes research and health services research. Note:
Studies falling under Exemption 4 for human subjects research are not
considered clinical research by this definition.

For this MCRC program, neither animal studies nor clinical
trials (of any phase) should be included.

A meritorious research base that encompasses
diseases/conditions within the NIAMS mission and provides professional and
patient resources for developing clinical projects;

A methodology core that will 1) play a key role in providing
support for multidisciplinary approaches for clinical projects within and
outside the MCRC and 2) contribute to the clinical research training
environment of the center; and

A minimum of two highly meritorious clinical research
projects that 1) target one or more of the diseases/conditions within the NIAMS
mission, and 2) each utilizes the methodology core.

Optional elements of an MCRC are:

A pilot/feasibility
project (no more than one may be proposed) supported by the methodology core
and

New
Renewal
Revisions
The OER
Glossary and the PHS398 Application Guide provide details on these application
types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH
appropriations, and the submission of a sufficient number of meritorious
applications.

NIAMS intends to fund up to three awards, corresponding to
a total of $3.6M, for fiscal year 2013. Future year amounts will depend on
annual appropriations.

Award Budget

An applicant may request a project period of up to 5 years
and a budget for direct costs up to $800,000 per year exclusive of facilities
and administrative costs of subcontracts with collaborating organizations.

Award Project Period

Scope of the proposed project should determine the project
period. The maximum period is 5 years. For the pilot/feasibility project (no
more than one may be proposed) supported by the methodology core in the P60,
a yearly budget of up to $50,000 in direct costs for no more than three years
may be requested.

NIH grants policies as
described in the NIH
Grants Policy Statement will apply
to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

Public/State Controlled Institutions of Higher Education

Private Institutions of Higher Education

The following types of Higher Education Institutions
are always encouraged to apply for NIH support as Public or Private
Institutions of Higher Education:

Non-domestic (non-U.S.) Entities (Foreign Institutions) are
not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH
Grants Policy Statement, are not allowed.

Required Registrations

Applicant organizations must complete the following registrations
as described in the PHS398 Application Guide to be eligible to apply for or
receive an award. Applicants must have a valid Dun and Bradstreet Universal
Numbering System (DUNS) number in order to begin each of the following
registrations.

All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s))
must also work with their institutional officials to register with the eRA
Commons or ensure their existing eRA Commons account is affiliated with the eRA
Commons account of the applicant organization.

All registrations must be completed by the application due
date. Applicant organizations are strongly encouraged to start the registration
process at least four (4) weeks prior to the application due date.

Eligible Individuals (Program Director(s)/Principal Investigator(s))

Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director(s)/Principal
Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH support.

Applicant organizations may submit more than one application,
provided that each application is scientifically distinct.

NIH will not accept any application in response to this FOA
that is essentially the same as one currently pending initial peer review
unless the applicant withdraws the pending application. NIH will not accept any
application that is essentially the same as one already reviewed.

Section
IV. Application and Submission Information

1. Address to Request Application Package

Applicants are required to prepare applications according to
the current PHS 398 application forms in accordance with the PHS 398
Application Guide.

2. Content and
Form of Application Submission

It is critical that applicants follow the instructions in
the PHS398
Application Guide, except where instructed in this funding opportunity
announcement to do otherwise. Conformance to the requirements in the
Application Guide is required and strictly enforced. Applications that are out
of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

Although a letter of intent is not required, is not binding,
and does not enter into the review of a subsequent application, the information
that it contains allows IC staff to estimate the potential review workload and
plan the review.

By the date listed in Part 1. Overview
Information, prospective applicants are asked to submit a letter of intent
that includes the following information:

Applications must be prepared using the PHS 398 research
grant application forms and instructions for preparing a research grant
application. Submit a signed, typewritten original of the application,
including the checklist, and three signed photocopies in one package to:

All page limitations described in the PHS398 Application
Guide and the Table of
Page Limits must be followed, with the following requirements:

Narrative sections: 12 pages, excluding Letters of Support

Research Strategy section for each individual project and core:
12 pages

Pilot/Feasibility projects (if applicable): 6 pages

Research Plan

All instructions in the PHS398 Application Guide must be
followed, with the following additional instructions:

Resource Sharing Plan

Individuals are required to comply with the
instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model
Organisms, and Genome Wide Association Studies (GWAS) as provided in the PHS398
Application Guide, with the following modification:

All applications, regardless of the amount of direct costs
requested for any one year, should address a Data Sharing Plan.

Appendix

Do not use the appendix to circumvent page limits. Follow
all instructions for the Appendix (please note all format requirements) as
described in the PHS398 Application Guide.

Applications must be received on or before the due dates in Part I. Overview Information. If an
application is received after that date, it will not be reviewed.

Upon receipt, applications will be evaluated for
completeness by the Center for Scientific Review and responsiveness by components of participating organizations,
NIH. Applications that are incomplete and/or nonresponsive will not be
reviewed.

Applicants are required to follow the instructions for
post-submission materials, as described in NOT-OD-10-115.

Section
V. Application Review Information

1. Criteria

Only the review criteria
described below will be considered in the review process. As part of the NIH mission, all applications submitted to the
NIH in support of biomedical and behavioral research are evaluated for
scientific and technical merit through the NIH peer review system.

Overall Impact

Reviewers will provide an overall impact/priority score to
reflect their assessment of the likelihood for the entire MCRC) to exert a sustained, powerful influence on the research field(s) involved, in consideration
of the following review criteria and additional review criteria (as applicable
for the overall MCRC and its components proposed). This overall
impact/priority score will reflect not only the quality of the individual projects,
cores, and administration, but also how the proposed MCRC will bring together
all these elements into a workable unit. The overall score may be higher or
lower than the "average" of the descriptors based on the assessment
of whether the "whole is greater that the sum of its parts..

Review Criteria - Overall Application

Reviewers will consider each of the review criteria below in
the determination of scientific merit,. An application does not need to be
strong in all categories to be judged likely to have major scientific impact. For
example, a project that by its nature is not innovative may be essential to
advance a field.

Significance

Does the proposed MCRC address an important problem
or a critical barrier to progress in the field? If the aims of the MCRC and its components are achieved, how will scientific knowledge, technical capability,
and/or clinical practice be improved? How will successful completion of the
aims change the concepts, methods, technologies, treatments, services, or
preventative interventions that drive this field? Do the Director and Associate Director have the leadership and research qualifications to lead a
Center? Does the leadership team (Director, Associate Director, and executive
committee) have the collective expertise to assure focused development and
implementation of high quality and meaningful clinical research projects?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other
researchers well suited to the MCRC and its components? If Early Stage
Investigators or New Investigators, or in the early stages of independent
careers, do they have appropriate experience and training? If established, have
they demonstrated an ongoing record of accomplishments that have advanced their
field(s)? If the project is collaborative or multi-PD(s)/PI(s), do the
investigators have complementary and integrated expertise; are their leadership
approach, governance and organizational structure appropriate for the project?

Innovation

Does the application challenge and seek to shift
current research or clinical practice paradigms by utilizing novel theoretical
concepts, approaches or methodologies, instrumentation, or interventions? Are
the concepts, approaches or methodologies, instrumentation, or interventions
novel to one field of research or novel in a broad sense? Is a refinement,
improvement, or new application of theoretical concepts, approaches or
methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the MCRC? Are potential problems, alternative strategies, and benchmarks for success presented?
If the MCRC is in the early stages of development, will the strategy establish
feasibility and will particularly risky aspects be managed?

If the MCRC involves clinical research, are the plans for 1) protection of
human subjects from research risks, and 2) inclusion of minorities and members
of both sexes/genders, as well as the inclusion of children, justified in terms
of the scientific goals and research strategy proposed?

Environment

Will the scientific environment in which the work
will be done contribute to the probability of success? Are the institutional
support, equipment and other physical resources available to the investigators
adequate for the project proposed? Will the MCRC benefit from unique features
of the scientific environment, subject populations, or collaborative
arrangements? Is there evidence of sufficient institutional commitment for the
MCRC? Will the MCRC add an important multidisciplinary element to the
institutional environment? Does the proposed MCRC utilize available resources
well?

Research Base

Is there a substantial productive and funded research
base? Is the research base sufficiently broad to foster new multidisciplinary
research? Is there a definition of who will be a Center investigator and what
this designation might mean? Does the application convey how the proposed MCRC
will enhance the research base of the host institution?

Integration

Does the proposed MCRC leverage existing
institutional resources? Is there evidence of interaction between the proposed
clinical projects and the methodology core? Are there clear advantages of
conducting the proposed research as MCRC rather than through separate research
efforts?

Past Progress of a Renewal MCRC (IF APPLICABLE):

Does the progress report reflect significant
accomplishments and impact of the MCRC during the last funding cycle? Is the
work of the MCRC reflected in new concepts and publications?

Reviewers will consider each of the review criteria below in
the determination of scientific merit, and give a separate score for each. The
overall impact/priority score will take into consideration: the scored review
criteria and any specified additional review criteria; the extent to which the
individual project enhances the strength of the overall MCRC; and the importance
of the individual project to the success of the MCRC. An application does not
need to be strong in all categories to be judged likely to have major
scientific impact. For example, a project that by its nature is not innovative
may be essential to advance a field.

Significance

Does the project address an important problem or a
critical barrier to progress in the field? If the aims of the project are
achieved, how will scientific knowledge, technical capability, and/or clinical
practice be improved? How will successful completion of the aims change the
concepts, methods, technologies, treatments, services, or preventative
interventions that drive this field? If a Pilot/Feasibility project is
proposed, is it likely to yield meaningful preliminary data as the basis for
the development of a successful full-scale research application?

Investigators

Are the PD(s)/PI(s), collaborators, and other
researchers well suited to the project? If Early Stage Investigators or New
Investigators, do they have appropriate experience and training? If
established, have they demonstrated an ongoing record of accomplishments that
have advanced their field(s)? If the project is collaborative or multi-PD(s)/PI(s),
do the investigators have complementary and integrated expertise; are their
leadership approach, governance and organizational structure appropriate for
the project?

Innovation

Does the application challenge and seek to shift
current research or clinical practice paradigms by utilizing novel theoretical
concepts, approaches or methodologies, instrumentation, or interventions? Are
the concepts, approaches or methodologies, instrumentation, or interventions
novel to one field of research or novel in a broad sense? Is a refinement,
improvement, or new application of theoretical concepts, approaches or
methodologies, instrumentation, or interventions proposed? If a Pilot/Feasibility
project is proposed, is the research topic one that promotes innovative
research related to the MCRC?

Approach

Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the project?
Are potential problems, alternative strategies, and benchmarks for success
presented? If the project is in the early stages of development, will the
strategy establish feasibility and will particularly risky aspects be managed?
Does the project utilize the multidisciplinary resources of the MCRC,
especially the Methodology Core? If a Pilot/Feasibility project is proposed,
does the project utilize the multidisciplinary resources of the MCRC,
especially the Methodology Core and does it employ useful collaborative
arrangements?

Are the plans for 1) protection of human subjects
from research risks, and 2) inclusion of minorities and members of both
sexes/genders, as well as the inclusion of children, justified in terms of the
scientific goals and research strategy proposed?

Environment

Will the scientific environment in which the work
will be done contribute to the probability of success? Are the institutional
support, equipment and other physical resources available to the investigators
adequate for the project proposed? Will the project benefit from unique
features of the scientific environment, subject populations, or collaborative
arrangements? If a Pilot/Feasibility project is proposed, is the project
appropriate to the research base of the center? Does one or more of the cores
offer needed materials/assistance?

Review Criteria for the Methodology Core:

The required Methodology Core must provide essential
methodological, biostatistical and educational functions as well as maintenance
of data integrity and development of safety plans for all projects in the MCRC.
The merit of the Methodology Core will be assessed based on the following
criteria:

Purpose

Is the proposed Methodology Core well matched to the
needs of the overall MCRC? Does it serve all research projects proposed for the
Center? Are unique services offered? Is the process for maintenance of data
integrity and assistance with development of safety plans for the projects
supported by the MCRC adequately addressed? Is there evidence that the
Methodology Core can and will support clinical research projects in more than
one chronic disease or condition of interest to the NIAMS?

Quality and Quality Control

What is the overall quality of the proposed core
services? Are there adequate quality control processes proposed for the
services provided by the Methodology Core (including procedures, techniques,
and quality control)? What are the criteria for prioritization and usage of
Core products and/or services? Is the Methodology Core likely to promote
multidisciplinary research?

Leadership

Are the qualifications, experience, and commitment of
the leader of the Methodology Core and other key personnel adequate and
appropriate for providing the proposed services?

Cost-effectiveness

Is the core cost effective? How is cost reimbursement
proposed?

Environment

Is the environment for the Methodology Core adequate
and appropriate to support the MCRC as proposed? Are the facilities and
equipment adequate and appropriate? Is there evidence of institutional support?

Training Activities

Does the methodology core propose an adequate plan
for enhancing the clinical training environment at the center? Will the core
provide opportunities such as seminars, courses, workshops or computer based
training to enhance the capabilities of faculty, staff, students and fellows
associated with the center to conduct clinical research using a wide range of
approaches?

Review Criteria for the Other Cores (if applicable):

Purpose

Is the proposed Core well matched to the needs of the
overall program? Will the core have utility to at least two of the MCRC
projects? Do the services offered best fit within a core structure? If this is
an add-on to a preexisting core, what is the benefit to the MCRC over direct
purchase of services from the existing core?

Quality and Quality Control

What is the overall quality of the proposed core
services? Is the quality of services high? Are there procedures for quality
control?

Leadership

Are the qualifications, experience, and commitment of
the leader of the Core and other key personnel adequate and appropriate for
providing the proposed facilities or services?

Cost Effectiveness

Is the core cost effective? If the core
offers new services that may be used by non-MCRC funded projects, how will the
non-MCRC funded projects purchase these services from the core?

Environment

Are the facilities and equipment adequate? Is there
institutional commitment to the core?

Review Criteria for the Administrative Core:

The Administrative Core provides for leadership and
management of all MCRC activities. The merit of the Administrative Core will be
assessed based on the following unscored criteria:

Purpose

Is the proposed Administrative Core well matched to
the needs of the overall center?

Management

Is the management proposed appropriate for scientific
administration as well as fiscal administration, procurement, property and
personnel management, planning, budgeting, etc.? Are there scientific and
administrative leadership, commitment and ability, and adequate time commitment
of the MCRC Director and Associate Director for the effective management of the
MCRC program?

Leadership

Do the Director and Associate Director have the
leadership and research qualifications to lead a MCRC? Do the proposed MCRC
Director, Associate Director and executive committee have the collective
expertise and leadership to identify and focus research projects on clinically
relevant issues?

Communication

Is there an appropriate plan for establishment and
maintenance of internal communication and cooperation among the MCRC
investigators, core leaders and executive committee? Are there appropriate plans
for outside review and input?

Environment

Is the environment for the Administrative
Core adequate and appropriate to support the overall program project as
proposed? Is there evidence of institutional support for the management of the MCRC?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining
scientific and technical merit, and in providing an overall impact/priority
score, but will not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46,
the committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials. For
additional information on review of the Human Subjects section, please refer to
the Human
Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of
minorities and members of both genders, as well as the inclusion of children. For
additional information on review of the Inclusion section, please refer to the Human
Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live
vertebrate animals as part of the scientific assessment according to the
following five points: 1) proposed use of the animals, and species, strains,
ages, sex, and numbers to be used; 2) justifications for the use of animals and
for the appropriateness of the species and numbers proposed; 3) adequacy of
veterinary care; 4) procedures for limiting discomfort, distress, pain and
injury to that which is unavoidable in the conduct of scientifically sound
research including the use of analgesic, anesthetic, and tranquilizing drugs and/or
comfortable restraining devices; and 5) methods of euthanasia and reason for
selection if not consistent with the AVMA Guidelines on Euthanasia. For
additional information on review of the Vertebrate Animals section, please
refer to the Worksheet
for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures
proposed are potentially hazardous to research personnel and/or the environment,
and if needed, determine whether adequate protection is proposed.

Resubmissions

Resubmissions applications are not permitted in
response to this FOA.

Renewals

For Renewals, the committee will consider the
progress made in the last funding period.

Revisions

For Revisions, the committee will consider the
appropriateness of the proposed expansion of the scope of the project. If the
Revision application relates to a specific line of investigation presented in
the original application that was not for recommended approval by the
committee, then the committee will consider whether the responses to comments
from the previous scientific review group are adequate and whether substantial
changes are clearly evident.

Additional Review Considerations

As applicable for the project proposed, reviewers will
consider each of the following items, but will not give scores for these items,
and should not consider them in providing an overall impact/priority score.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in
this section of the application, including 1) the Select Agent(s) to be used in
the proposed research, 2) the registration status of all entities where Select
Agent(s) will be used, 3) the procedures that will be used to monitor
possession use and transfer of Select Agent(s), and 4) plans for appropriate
biosafety, biocontainment, and security of the Select Agent(s).

Reviewers will consider whether the budget and the
requested period of support are fully justified and reasonable in relation to
the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group(s) convened by the NIAMS , in accordance with NIH peer
review policy and procedures, using the stated review
criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

May undergo a selection process in which only those applications
deemed to have the highest scientific and technical merit (generally the top
half of applications under review), will be discussed and assigned an overall
impact/priority score.

Will receive a written critique.

Applications will be assigned to the appropriate NIH Institute or Center and will compete for available funds with all
other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of
review by the National Arthritis and Musculoskeletal and Skin Diseases Advisory
Council . The following will be considered in making funding decisions:

Scientific and technical merit of the proposed project as
determined by scientific peer review.

Availability of funds.

Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the
PD(s)/PI(s) will be able to access his or her Summary Statement (written
critique) via the eRA Commons.

If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH
Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.

A final progress report, invention
statement, and the expenditure data portion of the Federal Financial Report are
required for closeout of an award, as described in the NIH
Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of
2006 (Transparency Act), includes a requirement for awardees of Federal grants
to report information about first-tier subawards and executive compensation
under Federal assistance awards issued in FY2011 or later. All awardees of
applicable NIH grants and cooperative agreements are required to report to
the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH
Grants Policy Statement for additional information on this reporting
requirement.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and
under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.